OXFORD CONFERENCE ON INNOVATION AND TECHNOLOGY TRANSFER FOR GLOBAL HEALTH University of Oxford.

OXFORD CONFERENCE ON INNOVATION AND TECHNOLOGY TRANSFER FOR GLOBAL HEALTH

University of Oxford

BRIDGING THE GAP IN GLOBAL HEALTH

INNOVATION:FROM NEEDS TO

ACCESS

9-13 September 2007

HEALTH INNOVATION:

THE NEGLECTED CAPACITY OF DEVELOPING

COUNTRIES TO ADDRESS NEGLECTED DISEASES

Carlos MorelOswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil

Plenary lecture4

PURPOSE:

To address all round

tables of this Oxford

Conference through the biased lens

of a developing

country citizen,

researcher and

decision-maker

1st Round Table5

Global, neglected and most neglected diseases (WHO &

MSF)6

World pharmaceutical market(>$600 bn in 2005)

Most neglected diseases(e.g. dengue, Chagas)

Neglected diseases(e.g. malaria, tuberculosis)

Global diseases(e.g. measles, diabetes)

Understanding global inequalities

Private health spending Malaria cases

Dorling D (2007) Worldmapper: The Human Anatomy of a Small Planet. PLoS Medicine 4(1)13-18

7

8

Public opinion sees illegal drugs

as a major problem all over

Africa

9

On the other hand the need to pay for medical and health care seems to vary among countries (e.g. Uganda x Mali)

Neglected tropical diseases

“The neglected tropical diseases are a group of

13 major disabling

conditions that are among the most common chronic infections in the world's poorest people”

10

Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:1018-1027

11 Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:1018-1027

Relationships between science, technology and

production12

Francisco Sagasti. Knowledge and innovation for development. The Sisyphus challenge of the 21st century, Cheltenham, UK; Northampton, USA:Edward Elgar, 2004. 151 pages

The Sisyphus challenge in Chile…

13

Scientometrics 72(1):93-103, 2007

The Sisyphus challenge in Chile…

14

“Developing countries share disbelief about the benefits of the

endogenous production of science as a tool for economical growth. Hence, public policies to strengthen science

and technology and promote the culture of innovation are, in general,

weak and sometimes incoherent”

Scientometrics 72(1):93-103, 2007

… and in Brazil15

Morel et al (2007) The road to recovery. Nature 449, in press

Entrepreneurship as ‘Conceptual Orphan’

“While the role of entrepreneurs and

entrepreneurship has never been denied, its most debilitating facet

is its limited, often cursory, coverage by the great thinkers on

economics and business”…

Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4

16

Entrepreneurship as ‘Conceptual Orphan’

17


2nd Round Table18

Forms of knowledge and modes of innovation (Jensen et al, 2007)19

I. Science, Technology and Innovation - STI Based on the production and use of codified

scientific and technical knowledge (“explicit knowledge”)

High priority to the production of “know-why” Emphasis on the use of information and

communication technology as tools for codifying and sharing knowledge

“Global” knowledgeJensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of

knowledge and modes of innovation. Research Policy 2007, 36:680-693.

Forms of knowledge and modes of innovation (Jensen et al, 2007)

II. Doing, Using and Interacting - DUI Relies on informal processes of learning

and experience-based know how High priority to the production of “know

how” and “know who” Strategies emphasizing the role played

by informal communication and communities of practice in mobilizing tacit knowledge for problem-solving and learning

“Local” knowledge

20

Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:680-693.

Forms of knowledge and modes of innovation (Jensen et al, 2007)

Know-whatKnow-why

Know-howKnow-who

Emphasis on STI mode

Emphasis on DUI mode

21


Forms of knowledge and modes of innovation (Jensen et al, 2007): Situations

Situation IOrganizations

are specialized in

one of the two modes

Situation II

Organizations try to

manage the two modes

STI DUI

STI DUI

22


Forms of knowledge and modes of innovation (Jensen et al, 2007): Indicators23


National Innovation & Learning Systems

24

ACTIVENIS

(Korea)

PASSIVE NLS

(Brazil)

25

National Innovation & Learning Systems

GDP per capitaKorea x Brazil, 1975-2004

26

1975Brazil: 5.502Korea: 3.722

2004Brazil: 7.531

Korea: 18.840

27

Science failures

Why: Insufficient knowledge Example: Unknown vaccines

Viral: Dengue, avian flu Bacterial: Leprosy, TB Parasitic: Malaria, leishmaniases, trypanosomiases

Need: Basic or “user-inspired” research; “Mode 2” of knowledge production (*)

Innovation modality New or improved products New R&D strategies: PDPs; PPPs (Brazil: Innovation

Law)(*) Gibbons M, Limoges C, Nowotny H, Schwartzman S, Scott P, Trow M: The new production

of knowledge: the dynamics of science and research in contemporary societies. London; Thousand Oaks; New Delhi: SAGE Publications; 1994

28

Market failures

Why: High costs prevent access to existing interventions or the development and production of cheaper ones

Example: antiretrovirals; combination therapies; new TB drugs

Need: Cheaper production processes; new funding strategies

Innovation modalities New methods/processes of production New funding policies (Push: PDPs; Pull: Global Funds)

New budgeting policies Increasing health budget (e.g. Brazilian taxation on financial

transactions) Decreasing health expenses (e.g. antiretrovirals IPR negotiations

between Governments and private sector)

29

Public health failures

Why: Lack of good governance or sound priorities; corruption; crises/war; cultural or religious factors; etc., prevent the access to cheap and readily available interventions

Examples Infectious diseases: polio vaccination (Religious or cultural factors);

leprosy chemotherapy (Brazil: wrong policy, lack of priority) Chronic diseases: obesity, tobacco (lobbying by multinational

companies) Needs: Education, civil society mobilization, human rights

approach Innovation modality: Process, strategy innovation

National Vaccination Days; WHO Tobacco Convention; educational TV campaigns (e.g. Brazilian soap operas with health messages); Tanzania’s experience in priority-setting in health systems (*)

(*) Savigny, Kasale, Mbuya, and Reid (2004) Fixing Health Systems

30

Science failure Market failure Public Health failure(knowledge/learning gap) (resources gap) (best practices gap)

New products, methods New processes New strategies or policies

Health Failures

Industrialized Countries

Innovative Developing Countries

Least Developed Countries

Ac

tio

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by

Na

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Health Innovations needed

A “health failures / innovations needed / country actions” matrix 31


Public funding of R&D (e.g. NIH genome projects of tropical pathogens)

Private sector participation at PDPs; Novartis/Singapore; Merck/Tres Cantos

North-South innovation networks; "Sister Institutions"/MIHR; CDTS/FIOCRUZ

"Bayh-Dole"-like laws to foster PDPs (e.g. Innovation Law/Brazil)

South-South networking with IDCs (e.g. FIOCRUZ/Brazil-ENSPA/Angola)

EDCTP-like clinical trials platforms


Health Failures




Ac

tio

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by

Na

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va

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33

Fighting science failures(knowledge gaps)

Fighting science failures(knowledge gaps)

34


Drug-donation mechanisms (e.g. Mectizam)

Differential pricing; corporate image polishing

Increasing health budget (e.g. taxation on financial transactions/Brazil)

Negotiating price reductions (e.g. IP on antiretrovirals/Brazil)

Funding mechanisms e.g. Global Fund, GAVI

Fighting counterfeit drugs; improving regulatory situation


Health Failures




Ac

tio

ns

by

Na

tio

na

l In

no

va

tio

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ys

tem

s



Fighting market failures (resources gap)

36


Donors (Rotary & polio; Sasakawa & leprosy; IDRC & priority setting)

Pressure through WHAs and Global Conventions (e.g. Tobacco; Kyoto)

Pressure from health sector and civil society (e.g. Brazil Constitution)

National vaccination days

Better priority setting (e.g. Tanzania's health budget/"for 80 cents more")

Educational campaigns; empowerment of women; fighting corruption


Health Failures




Ac

tio

ns

by

Na

tio

na

l In

no

va

tio

n S

ys

tem

s



Fighting public health failures(best practices gap)

38


Public funding of R&D (e.g. NIH genome projects of tropical pathogens)

Drug-donation mechanisms (e.g. Mectizam)

Donors (Rotary & polio; Sasakawa & leprosy; IDRC & priority setting)

Private sector participation at PDPs; Novartis/Singapore; Merck/Tres Cantos

Differential pricing; corporate image polishing

Pressure through WHAs and Global Conventions (e.g. Tobacco; Kyoto)

North-South innovation networks; "Sister Institutions"/MIHR; CDTS/FIOCRUZ

Increasing health budget (e.g. taxation on financial transactions/Brazil)

Pressure from health sector and civil society (e.g. Brazil Constitution)

"Bayh-Dole"-like laws to foster PDPs (e.g. Innovation Law/Brazil)

Negotiating price reductions (e.g. IP on antiretrovirals/Brazil)

National vaccination days

South-South networking with IDCs (e.g. FIOCRUZ/Brazil-ENSPA/Angola)

Funding mechanisms e.g. Global Fund, GAVI

Better priority setting (e.g. Tanzania's health budget/"for 80 cents more")

EDCTP-like clinical trials platformsFighting counterfeit drugs; improving

regulatory situationEducational campaigns; empowerment

of women; fighting corruption


Health Failures




Ac

tio

ns

by

Na

tio

na

l In

no

va

tio

n S

ys

tem

s



3rd Round Table40

Components of health innovation

41

Components of health innovation

42

Innovative Developing Countries, IDCs

(*) Morel et al (2005) Innovation Strategy Today 1(1):1-15

http://www.biodevelopments.org/innovation/index.htm

43

44

Innovative Developing Countries, IDCs



LDCs IDCs OECD and the six components of health innovation

45



6 components or

determinantsLDC

s ID

Cs

O

EC

D

The power of the emerging... IDCs!

46

Health Innovation Networks47

Morel et al (2005) Science 309:401-404, 2005

Developing Country Vaccine Manufactures’ Network Brazil, Cuba, China, India, Indonesia, Mexico

WHO Developing Countries’ Vaccine Regulators Network Brazil, China, Cuba, India, Indonesia, Russia, South Africa, South

Korea, Thailand

48

50

National Health Innovation System

Morel et al (2005) Science 309:401-404, 2005

Collaborative research network on leprosy involving Brazilian

researchers51


4th Round Table52

53

Health technology innovation: Major historical periods 1850-early 1900s’: Era of the public sectorEra of the public sector

Epitomized by the work of Pasteur 1900s’-1970s’: Era of the private sectorEra of the private sector

Emerged in Germany & chemical companies 1970s’-2000: Era of public sector Era of public sector

reawakeningreawakening United Nations: WHO Special Programmes (HRP,

TDR) USA: Bayh-Dole Act; NIH budget increase

2000- : Era of public-private partnerships Era of public-private partnerships (PPPs)(PPPs) Product Development Partnerships (PDPs) Innovative Developing Countries (IDCs) Health Innovation Networks

Mahoney, R & Morel, C. (2006) A Global Health Innovation System (GHIS). Innovation Strategy Today 2(1):1-12

54

Global health PPPs: productproduct-based and product-product-developmentdevelopment based

Buse K, Walt G (2000) Global public-private partnerships: parts I & II Bull.World Health Organ. 78(4): 549-561 & 78(5): 699-709

55

56

57

Mary Moran’s Pharmaceutical R&D Policy Project

58


Mary Moran’s

team identified

three categories of major

players in drug

development for

neglected and most neglected diseases

Multinational drug companies 32 projects Working with PPPs or alone on a non-

commercial basis Smaller scale commercial firms

60-plus projects Working with PPPs on a commercial

basis Drug development PPPs

47 projects Working with large and small

companies

59


60

Types of global health partnerships

61

There is today a large

number of global

health PPPs focusing on neglected and most neglected diseases. They are

quite different in

terms of vision and

goals.

Partnerships focusing at reducing financial risks of drug development MMV; TB Alliance

Partnerships focusing on public health and capacity building of endemic countries UN Special Programmes (HRP; TDR) Developing Country Vaccine

Manufactures’ Network WHO Developing Countries’ Vaccine

Regulators Network Partnerships addressing both goals

DNDi

Health PDPs: Broad range of mandates

Partnership focuses on product development and registration; minimal or no involvement of developing countries Most PDPs involving

multinational drug companies

Partnership’s mandate includes issues such as capacity building; training; involvement of endemic country institutions and public health WHO/country networks UN Special

Programmes

“Development as Growth” (*)

“Development as Freedom” (A. Sen)(*)

62

(*) Personal communication - Margaret Chon, Seattle University School of Law

A spectrum of global health PPPs

Nature of PPPs’visions and mandates

Focus on financial

risk reductio

n

Focus on increasin

g capacity

and public health

63

A spectrum of global health PPPs

Nature of PPPs’visions and mandates

Focus on financial

risk reductio

n

Focus on capacity building

and public health

64

DCVR (Developing Countries' Vaccine Regulators) Network

Mary Moran’s Pharmaceutical R&D Policy Project: PPP timelines65

66

Standard industry

metrics, as used by Moran’s project,

should be regarded as

just one component

of a broader set of metrics

when analyzing

Global PPPs of different

nature

Involvement of developing country partners National Innovation

Systems GLP, GCP, GMP Regulatory agencies

Strengthening local health systems & services

Mary Moran’s Pharmaceutical R&D Policy Project: Performance metrics

5th Round Table67

Intellectual property rights and innovation in developing countries

68

IP not protected

IP strongly

protected

Chen Y, Puttitanun T: Intellectual property rights and innovation in developing countries. Journal of Development Economics 2005, 78:474-493.

Chen Y, Puttitanun T: Intellectual property rights and innovation in developing countries. Journal of Development Economics 2005, 78:474-493.

Intellectual property rights and innovation in developing countries

69

IP protection due

to externa

l pressur

e

IP protection by

country decisio

nIP policy in

transition

IP and compulsory licences70

IP management in health

To address IP management

and licensing, one

of the six components of

health innovation, developing

countries need to train human resources and

strengthen their

institutions in this critical

area

Public Health, Innovation and IP

Resolution of the World Health

AssemblyIntergovernmental Working Group on

Public Health, Innovation and

Intellectual Property (IGWG)

http://www.who.int/phi/documents/en/

73

Public Health, Innovation and IP

74

Secretariat for Public Health, Innovation and Intellectual Property (PHI) Established in September 2006 Mandate

Facilitate implementation of Resolution WHA 59.24

Follow-up to the report of the Commission on Intellectual Property Rights, Innovation and Public Health

Resolution WHA 59.24 & IGWG

75

Intergovernmental Working Group (IGWG) Mandate

Global Strategy and Plan of Action “Securing an enhanced and sustainable basis for

needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries”

Submission to the Sixty-first World Health Assembly in May 2008

http://www.who.int/phi/en/ What next? May 2008 is approaching rapidly

http://www.who.int/phi/en/

Intergovernmental Working Group (IGWG)

76

Final product should go beyond a WHA resolution

The “Global Strategy and Plan of Action” will need to be institutionalized / hosted at a suitable home or platform Expertise in neglected diseases R&D Good interface with industry and PDPs Balanced governance involving developed

and developing countries Proven record of implementation capacity Long term vision and strategic thinking

6th Round Table77

Financing for what kind of innovation?

78


The challenge of financing technological innovation: Vaccines79

Historical models of vaccine development Predominantly private sector development

Hepatitis B (HBV) vaccine: Merck Public (or nonprofit) sector vaccine design,

with handover to the private sector for trials and manufacturing Human papillomavirus (HPV) vaccine

Predominantly public-sector development Influenza vaccine: US Army

Coordination by a nonprofit entity Salk polio vaccine

IAVI Policy Research Working Paper #14 - R&D Models: Lesson from Vaccine History

The challenge of financing technological innovation: Vaccines80

Expanded Program for Immunization (EPI) vaccines $0.25 per dose; $1.50 total cost/child

New, non-EPI vaccines can cost 10x more $13.50 per fully immunized child The example of Dominican Republic

Budget of current national immunization program: $658,190

Addition of hepatitis b vaccine: additional $590,040

Addition of Hib vaccine: additional $2,880,000

Mahoney et al, Vaccine 18:2625-2635, 2000

Commercial trade of pharmaceuticals in Brazil

81


82

Evolution of Latin America’s economies

Brazil: Health expenditures, per capita (US$)

83

Brazil: Health expenditures, per capita (US$)

84

2002-05:

59.5% u

p

Public expenditure in health for selected countries (US$ per

capita, 2003)85

Country US$

USA 2,548

Germany 2,506

France 2,273

UK 2,081

Japan 1,997

Canada 1,886

Australia 1,699

Cuba 183

Mexico 172

Brazil 153

Argentina 148

Chile 137

Financing: It is not only money that counts

“Brazil’s approach to the HIV/AIDS epidemic has been characterized by an early public sector response, strong civil society participation, multisectoral mobilization of efforts and resources, a balanced and comprehensive

approach to prevention and treatment and the inclusion of a human rights perspective in all strategies”

86

Financing for what kind of innovation?

87

Gardner et al, Health Affairs 2007, 26(4):1052-1061.

88

89

Science 317:482-487, 27/July/2007

Thank [email protected]

Carlos MorelOswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil

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OXFORD CONFERENCE ON INNOVATION AND TECHNOLOGY TRANSFER FOR GLOBAL HEALTH University of Oxford.

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